THE TGA has warned that Robust Extreme capsules pose a serious risk to public health and should not be taken.
The regulatory authority has tested Robust Extreme capsules and found that they contain the undeclared substance o-propyl vardenafil, which is an analogue of vardenafil.
The drug taken in combination with other medications can cause serious side effects, said the TGA.
The medicine may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels, the authority stated.
People with diabetes, high blood pressure, high cholesterol or heart disease are often prescribed nitrates.
Pharmacy customers should be advised that vardenafil is a prescription-only substance in Australia, stated the TGA.
The supply of Robust Extreme capsules containing undisclosed vardenafil is illegal.
The capsules have not been assessed by the TGA for quality, safety or efficacy as required under legislation, and the place of manufacture is not approved.
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